Abstract Details

Title The Safety and Efficacy of Subcutaneous Forms of Levodopa/Carbidopa (ND0612 and Foslevodopa/ Foscarbidopa) on Parkinson’s Disease Patients: Systematic Review and Meta Analysis

Topic Movement Disorders

Presentation(s) P11 - Poster Session 11 (8:00 AM-9:00 AM)

Poster/Presentation
Number 5-030

Objective The safety and efficacy of subcutaneous forms of levodopa/carbidopa.

Background Parkinson's is a motor degenerative disease. The cardinal motor manifestations of Parkinson disease are postural instability, short shuffling gait, cogwheel rigidity of extremities and head, tremors at rest, writing changes (e.g. small handwriting) and bradykinesia . The known and acceptable treatment is oral levodopa/carbidopa but the patients experience (on off phenomenon) where the patients encounter sudden halt of the drug effect so subcutaneous sustained release form is now in trials to assess its efficacy and safety.

Design/Methods We searched six different databases for RCTs and single arm studies until November 2024 to screen included studies talking about Subcutaneous forms of levodopa/carbidopa such as subcutaneous levodopa/carbidopa known as ND0612 and Foslevodopa/Foscarbidopa known as ABBV-951. We included 6 studies (2 RCTs and 4 single arm studies). There were adverse events related to the drug such as hallucinations and anxiety and adverse events related to infusion site such as infusion site nodules and infusion site erythema.

Results 658 total patients, of which 565 experienced side effects with a percentage of 85.86%. ND0612: subcutaneous levodopa/carbidopa, patients experienced 263 side effects events while ABBV-951: Foslevodopa/Foscarbidopa, experienced a total of 256 side effects events. Continuation of subcutaneous form is accompanied with serious adverse events related to the infusion site: complications like pain, erythema, nodules, cellulitis, haemorrhage and hematoma and events leads to discontinuation. there were also drug related adverse events in some studies such as hallucinations and anxiety.

Conclusions Our pooling analysis focused on serious and highly distressing adverse effects related to the site of infusion of subcutaneous forms of ND0612 and ABBV-951 which evoked strong negative reactions in patients leading to high rate of discontinuation. Limitations: our analysis included single arm studies. Implications of this study include a need for further research with an extended follow-up period.

Authors/Disclosures
Ram K. Saha, MD (Virginia Commonwealth University) PRESENTER	Dr. Saha has nothing to disclose.
Ahmed S. Fathy, Jr., student	Dr. Fathy has nothing to disclose.
Rahma A. Ibrahim	Ms. Ibrahim has nothing to disclose.
Shahd Al Haj Ali, MD	Dr. Al Haj Ali has nothing to disclose.
Yousef H. Saad, Jr., MD	Mr. Saad has nothing to disclose.
Ahmed Nazmy, MBBS	Dr. Abd El Aziz has nothing to disclose.
Salma N. Nasser, MD	Dr. Nasser has nothing to disclose.
Nada A. Hegazy, PhD	Dr. Hegazy has nothing to disclose.
Ahmed M. Shaheen	Dr. Shaheen has a non-compensated relationship as a A Research Position Candidate Under Trial Task with Solvemed Company that is relevant to AAN interests or activities.

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